Ziagen

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Hypersensitivity to abacavir
is a multi-organ clinical syndrome usually characterized by a sign or symptom
in 2 or more of the following groups: (1) fever, (2) rash, (3) gastrointestinal
(including nausea, vomiting, diarrhea, or abdominal pain), (4) constitutional
(including generalized malaise, fatigue, or achiness), and (5) respiratory
(including dyspnea, cough, or pharyngitis). Discontinue ZIAGEN as soon as a
hypersensitivity reaction is suspected.

Patients who carry the
HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction
to abacavir. Prior to initiating therapy with abacavir, screening for the
HLA-B*5701 allele is recommended; this approach has been found to decrease the
risk of hypersensitivity reaction. Screening is also recommended prior to
reinitiation of abacavir in patients of unknown HLA-B*5701 status who have
previously tolerated abacavir. HLA-B*5701-negative patients may develop a
suspected hypersensitivity reaction to abacavir; however, this occurs
significantly less frequently than in HLA-B*5701-positive patients.

Regardless of HLA-B*5701
status, permanently discontinue ZIAGEN if hypersensitivity cannot be ruled out,
even when other diagnoses are possible.

Following a hypersensitivity
reaction to abacavir, NEVER restart ZIAGEN or any other abacavir-containing
product because more severe symptoms can occur within hours and may include
life-threatening hypotension and death.

Reintroduction of ZIAGEN or
any other abacavir-containing product, even in patients who have no identified
history or unrecognized symptoms of hypersensitivity to abacavir therapy, can
result in serious or fatal hypersensitivity reactions. Such reactions can occur
within hours [see WARNINGS AND PRECAUTIONS].

Lactic Acidosis and Severe
Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogues alone or
in combination, including ZIAGEN and other antiretrovirals [see WARNINGS AND
PRECAUTIONS].

DRUG DESCRIPTION

ZIAGEN is the brand name for abacavir sulfate, a
synthetic carbocyclic nucleoside analogue with inhibitory activity against
HIV-1. The chemical name of abacavir sulfate is (1S,cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol
sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute
configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4
and a molecular weight of 670.76 daltons. It has the following structural
formula:

Abacavir sulfate is a white to
off-white solid with a solubility of approximately 77 mg/mL in distilled water
at 25°C. It has an octanol/water (pH 7.1 to 7.3) partition coefficient (log P)
of approximately 1.20 at 25°C.

ZIAGEN Tablets are for oral
administration. Each tablet contains abacavir sulfate equivalent to 300 mg of
abacavir as active ingredient and the following inactive ingredients: colloidal
silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium
starch glycolate. The tablets are coated with a film that is made of
hypromellose, polysorbate 80, synthetic yellow iron oxide, titanium dioxide,
and triacetin.

What are the precautions when taking abacavir sulfate (Ziagen)?

See also Warning and How to Use sections.

Before taking abacavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart...